Villa Radiology Systems LLC recalls Owandy Radiology I -MAX Touch 3D X-ray

Recall date

August 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0129-2016

FDA classification

Class II

Brand / firm

Villa Radiology Systems LLC

Sold / distributed

US Distribution

Why it was recalled

It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Owandy Radiology I -MAX Touch 3D X-ray